FDA Inspection
The Soule CompanyThe Soule Company – FDA Inspection, Sep 16, 2013
Record Details
This FDA Inspection record concerns The Soule Company, with an inspection on September 16, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- The Soule Company
- Inspection Date
- September 16, 2013
- Product Type
- Devices
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ID · ac7e68a9-9a6c-4a0d-96d9-9ea53453bbb5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 848620
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of The Soule Company
3| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 20, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 19, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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